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Safety and Efficacy of Anti-SARS-CoV-2 Equine Antibody Fragments (INOSARS) for Hospitalized Patients With COVID-19

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ClinicalTrials.gov Identifier: NCT04514302
Recruitment Status : Not yet recruiting
First Posted : August 14, 2020
Last Update Posted : August 14, 2020
Sponsor:
Information provided by (Responsible Party):
José Fernando Castilleja-Leal, Hospital San Jose Tec de Monterrey

Brief Summary:
This is a two-center, randomized, placebo-controlled pilot study of anti-SARS-CoV-2 equine immunoglobulin fragments F(ab')2 (INOSARS) to evaluate safety and preliminary efficacy in the treatment of hospitalized COVID-19 patients. Clinical improvement at 28 days from the start of treatment will be evaluated.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Placebo Drug: Anti-SARS-CoV-2 equine immunoglobulin fragments (INOSARS) Phase 1 Phase 2

Detailed Description:
This is a two-center, randomized, placebo-controlled pilot study of anti-SARS-CoV-2 equine immunoglobulin fragments F(ab')2 (INOSARS) to evaluate safety and preliminary efficacy in the treatment of hospitalized COVID-19 patients. Subjects included in the study are hospitalized adult patients with a diagnosis of COVID-19, that: 1) require supplementary oxygen or non-invasive mechanical ventilation OR 2) have clinical or imaging evidence of pneumonia OR 3) have laboratory markers of risk of disease progression (high levels of serum inflammatory markers). The sample size is 51 patients randomized to one of three arms: 18 patients to placebo, 16 patients to dose 1 and 17 patients to dose 2 of anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments. The safety outcome is the proportion of patients with early and late adverse events until the end of follow-up at 28 days, for both doses of treatment. The primary outcome is the proportion of patients with clinical improvement at 28 days from the start of treatment, comparing between both treatment groups vs placebo. Clinical improvement is defined as a reduction of 1 point in the NIAID 8-point ordinal scale of clinical status for COVID-19 patients or hospital discharge, whichever comes first.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blind
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate Safety and Efficacy of Anti-SARS-CoV-2 Equine Immunoglobulin F(ab')2 Fragments (INOSARS) in Hospitalized Patients With COVID-19
Estimated Study Start Date : October 20, 2020
Estimated Primary Completion Date : February 20, 2021
Estimated Study Completion Date : June 20, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Single dose of 150 mL of saline solution administered intravenously as an infusion at 4.0 mL/min over 40 min. n = 18.
Drug: Placebo
Placebo of saline solution of equal volume and infusion. Content of the infusion bag and tubing will be concealed with opaque covering.
Other Name: Control

Experimental: INOSARS dose 1
Single dose of 2 vials of INOSARS in 150 mL of saline solution administered intravenously as an infusion at 4.0 mL/min over 40 min. n = 16
Drug: Anti-SARS-CoV-2 equine immunoglobulin fragments (INOSARS)
INOSARS is a polyvalent passive immunization based on anti-SARS-CoV-2 immunoglobulin F(ab')2 fragments from hyperimmune equine serum. Inactive ingredients: water for injection, sodium chloride and less than 10% of total protein content.
Other Name: INOSARS

Experimental: INOSARS dose 2
Description: Single dose of 6 vials of INOSARS in 150 mL of saline solution administered intravenously as an infusion at 4.0 mL/min over 40 min. n = 17
Drug: Anti-SARS-CoV-2 equine immunoglobulin fragments (INOSARS)
INOSARS is a polyvalent passive immunization based on anti-SARS-CoV-2 immunoglobulin F(ab')2 fragments from hyperimmune equine serum. Inactive ingredients: water for injection, sodium chloride and less than 10% of total protein content.
Other Name: INOSARS




Primary Outcome Measures :
  1. Proportion of patients with improvement in clinical status [ Time Frame: 28 days ]
    The primary endpoint is the proportion of patients with clinical improvement at 28 days after treatment. Clinical improvement is defined as (whichever is first): a) hospital discharge or b) reduction of 1 point in the NIAID 8-point ordinal scale. Scale categories as follows: 1 = not hospitalized; 2 = not hospitalized with limitation of activities and/or oxygen requirement; 3 = hospitalized not requiring supplemental oxygen and not requiring active medical care, 4 = hospitalized requiring active medical care without requiring oxygen supplementation; 5 = hospitalized requiring oxygen supplementation; 6 = hospitalized requiring high-flow oxygen or non-invasive mechanical ventilation; 7 = hospitalized requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8 = death.


Secondary Outcome Measures :
  1. Time to clinical improvement [ Time Frame: 28 days ]
    Time from the day of treatment until the first day with clinical improvement, defined as (whichever is first): a) hospital discharge or b) reduction of 1 point in the NIAID 8-point ordinal scale.

  2. Proportion of patients that reach a score of 6, 7 or 8 in the NIAID 8-point ordinal scale [ Time Frame: 28 days ]
    Proportion of participant death or non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation requirement.

  3. Duration of hospitalization [ Time Frame: 28 days ]
    Measured in days

  4. SARS-CoV-2 PCR negativization rate [ Time Frame: 3 days ]
    Proportion of patients that have a negative polymerase chain reaction assay for SARS-CoV-2 at 72 hrs from start of treatment.

  5. Proportion of patients with clinical improvement at day 7 [ Time Frame: 7 days ]
    Proportion of patients with clinical improvement at day 7. Clinical improvement is defined as (whichever is first): a) hospital discharge or b) reduction of 1 point in the NIAID 8-point ordinal scale

  6. Proportion of patients with immediate adverse events (< 24 hours) [ Time Frame: 24 hours ]
    Proportion of patients that present within 24 hours of treatment with immediate adverse events defined as: skin rash and/or respiratory findings (dyspnea, wheezing, bronchospasm, hypoxia) and/or circulatory compromise (reduction of blood pressure or associated symptoms, i.e. syncope).

  7. Proportion of patients with late adverse events (1 - 28 days) [ Time Frame: 28 days ]
    Proportion of patients that present events associated with serum sickness (type 3 hypersensitivity), vasculitis, glomerulonephritis, arthritis.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects of both sexes aged ≥ 18 years
  • Patients with a confirmed infection with SARS-CoV-2 by PCR
  • Patients admitted for hospitalization for COVID-19 disease that fulfills any of the following:

    1. Clinical or imaging evidence of pneumonia defined as: SpO2 < 94% or PaO2/FiO2 (SpO2/FiO2) < 300 or chest imaging consistent with pneumonia or clinical evidence of pneumonia (fever, cough, dyspnea and respiratory frequency > 24 respirations/min) OR
    2. Score of 4 (hospitalized no oxygen requirement, requires medical care), 5 (hospitalized, low-flow oxygen requirement) or 6 (hospitalized, high-flow oxygen or non-invasive mechanical ventilation requirement) in the NIAID 8-point ordinal scale of clinical status for COVID-19
    3. High risk markers of disease progression (at least on serum inflammatory marker elevated: C reactive protein, D-dimer, lactate dehydrogenase, ferritin)
  • Agrees to participate in the study and signs written informed consent (signed by relative if applicable)

Exclusion Criteria:• Patients with known equine allergies

  • Patients with past medical history of serum sickness
  • Patients with more than 4 days of hospitalization before being randomized in study
  • Patients who have received convalescent plasma or intravenous immunoglobulin (IVIG) for COVID-19
  • Pregnant or breastfeeding women
  • Patients with chronic kidney disease under dialysis
  • Patients under invasive mechanical ventilation and/or extracorporeal membrane oxygenation at the beginning of study
  • Patients participating in another intervention clinical trial
  • Patients who are immunocompromised or with another chronic condition, that is judged by medical staff, to be at higher risk of infection or complications from participating in study
  • Patients who are judged by medical staff who are unlikely to survive at 48 hours

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04514302


Contacts
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Contact: Servando Cardona-Huerta, MD, Ph. D. +5218112121946 servandocardona@tec.mx
Contact: Alejandro Torres-Quintanilla, MD, MSc +528180205853 atorresq@tec.mx

Locations
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Mexico
Hospital San José
Monterrey, Nuevo Leon, Mexico, 64718
Sponsors and Collaborators
Hospital San Jose Tec de Monterrey
Investigators
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Principal Investigator: José F Castilleja-Leal, MD Wellness and Prevention Center
Publications:
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Responsible Party: José Fernando Castilleja-Leal, Wellness and Prevention Director, Hospital San Jose Tec de Monterrey
ClinicalTrials.gov Identifier: NCT04514302    
Other Study ID Numbers: INOSARS-CoV-2 TecSalud
First Posted: August 14, 2020    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by José Fernando Castilleja-Leal, Hospital San Jose Tec de Monterrey:
COVID-19
SARS-CoV-2
Immunoglobulin fragments
Additional relevant MeSH terms:
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Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
Immunoglobulin Fragments
Immunologic Factors
Physiological Effects of Drugs